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Questions and Answers on Ameridose Recall

Q1. What is FDA announcing?

A1. The U.S. Food and Drug Administration is announcing that Ameridose LLC is voluntarily recalling all of its unexpired products in circulation. The FDA recommended this recall based on the preliminary results of the FDA’s ongoing inspection, which has raised concerns for the FDA about a lack of sterility assurance for products produced at and distributed at Ameridose’s Westborough, Massachusetts facility. The ongoing FDA inspection is being conducted with the Massachusetts Board of Registration in Pharmacy.

Ameridose is managed by some of the same people as New England Compounding Center (NECC). This voluntary recall action by Ameridose is different from the NECC recall of products implicated in the multistate outbreak of fungal meningitis. This recall is out of an abundance of caution, because, to date, Ameridose products are not associated with the fungal meningitis outbreak and the FDA is not aware of any recent reports of infections in patients associated with Ameridose products.

Q2. What led FDA to take this action?

A2. Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose and NECC of Framingham, Mass. share some of the same managers. No product made by Ameridose has been associated with the fungal meningitis outbreak. On October 10, 2012, Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to temporarily cease all pharmacy and manufacturing operations.

Producers of medications must have adequate controls over their ingredients, facilities, and processes to assure that products are safe and effective, and meet quality standards. The preliminary findings from the inspection raise concerns for the FDA about a lack of sterility assurance for the firm’s products that purport to be sterile.

Sterile products must be prepared in areas where microbial burden is controlled. Lack of control over these conditions can lead to product contamination. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries.

Q3. Are patients at risk as a result of this recent recall?

A3. This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution. Therefore, at this time, the FDA is also recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm.

Q4. Which drugs are in shortage?

A4. FDA has identified six Ameridose products on the FDA critical shortage list, which already were in shortage prior to the recall. The recall has the potential to exacerbate one or more of these shortages:

Sodium Bicarbonate Injection

Succinylcholine Injection

Atropine Sulfate Injection

Bupivacaine Hydrochloride Injection

Lidocaine Hydrochloride Injection

Furosemide Injection

For these 6 drugs in shortage, these are the actions FDA will continue to take:

FDA is working with manufacturers for these 6 drugs, requesting that they ramp up production if they are willing and able to do so.

For any manufacturers for these 6 drugs that may be experiencing manufacturing/quality problems, FDA is offering assistance, where appropriate, to help address these problems to enable those manufacturers to manufacture shortage drug products that are safe and high quality.

If the manufacturers of critical drugs intended for the U.S. are not able to meet U.S. patient needs, FDA explores companies that are willing and able to import foreign drugs to address the shortage in the U.S. In these instances, FDA evaluates the foreign drug to ensure that it is of adequate quality and that the drug does not pose undue risks for U.S. patients.

As with shortages of any critical products, FDA will expedite the reviews of any pending applications that could help with addressing the shortages.

FDA is identifying any additional manufacturers willing to initiate or increase production.

Q5. What should health care providers do if they have Ameridose products?

A5. Healthcare professionals and clinics should not use any Ameridose products and should isolate all products for return to Ameridose. Ameridose voluntarily ceased production on Oct. 10, 2012, and no Ameridose products are currently being distributed by Ameridose.

Q6. What should healthcare professionals do to protect their patients?

A6. Healthcare professionals should stop using Ameridose products. Health care professionals do not need to follow up with patients who received Ameridose products at this time. All Ameridose products should be isolated and quarantined and then returned to the company.

Clinics, health care professionals, and other customers with Ameridose product on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to the company.

Patients who have questions or concerns should follow up with their healthcare professional.

FDA also asks healthcare professionals and consumers to report any adverse reactions to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Healthcare professionals and patients may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.

Q7. Will there be a list of Ameridose products or customers provided?

A7. A complete list of all products subject to this recall can be accessed at www.ameridose.com. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo.